Purpose :
FAc provides continuous microdosing of steroid (0.2 µg/day) for up to 3 years. In addition to clinical reduction in edema and visual acuity benefits, FAc has demonstrated neuroprotection in animal models of retinal degeneration. Given these potential benefits, this current, retrospective analysis examined the relationship between short and long-term changes in visual acuity in the FAME trial.

Methods :
Subjects from the FAME clinical trial who had received 0.2 µg/day FAc were categorized by visual acuity response (measured by BCVA) at Week 6. Three categories were determined: <5-letter improvement; 5–9-letter improvement; and ≥10-letter improvement from baseline. Mean change in BCVA from baseline was calculated over time for each group. At Month 36, BCVA change from baseline was analyzed and categorized as improved (≥5-letter improvement), stable (<4-letter change either way), or worsened (≥5-letter worsening). Change from baseline central subfield thickness (CST) at Month 36 was also assessed by Week 6 visual response.

Results :
Subjects received a mean number of injections of 1.3 over 36 months, with the subgroup that obtained greatest change from baseline BCVA at Week 6 showing consistent improvement in visual acuity over 36 months’ follow-up. Consequently, these subjects had the highest proportion with improved visual acuity (83.8%) at Month 36 (Table 1). However, even in those patients with worse BCVA at Week 6, stable or improved vision at Month 36 was observed in 79.1%.The only subgroup with no long-term response in terms of function or anatomy was the small proportion of patients (7.5%) who showed ≥10-letter BCVA improvement at Week 6, but, at Month 36 demonstrated a decrease in BCVA of ≥5 letters and did not experience any significant reduction in edema.

Conclusions :
These results show that most patients (85.7%) treated with 0.2 µg/day FAc experience improved or stable BCVA over 36 months and that over 90% experience improved or stable vision and an anatomic response. Surprisingly, 50.9% of patients who did not experience significant improvement in BCVA at Week 6 still developed improved vision at Month 36. These findings support the long-term benefit of continuous microdosing with 0.2 µg/day FAc.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.